Practice Parameter Development Process

JTF Composition and Member Selection

The Joint Task Force on Practice Parameters (JTFPP) is composed of six representatives from the AAAAI, six representatives from the ACAAI, and one representative from the JCAAI. These individuals
are selected by the sponsoring organizations.

In regard to replacing members of the JTFPP who retire from the JTFPP, the AAAAI and ACAAI have the ultimate responsibility for selection of an individual to replace such members. Making
such appointments however, should be a collaborative effort. The JTFPP will submit to the sponsoring organizations, a list of 2 - 4 individuals that they feel would work effectively on the
JTFPP. The AAAAI/ACAAI will review this list and work with the JTFPP to decide which individual would be most productive - based in part on the understanding by the JTFPP of the commitment that
is required. An attempt should be made to recommend individuals who are not only knowledgeable with the literature but who have demonstrated a commitment on previous projects and an ability to
work with colleagues toward a common goal. This is particularly important given the large workload that consistently faces the JTFPP.

JTF Administration

The administrative duties for the Joint Task Force on Practice Parameters are handled by the office of the Joint Council of Allergy, Asthma and Immunology
(JCAAI).

The AAAAI and ACAAI each contribute 45% of the total operational budget with the JCAAI contributing 10%.

The annual budget is submitted to the governing boards of each organization for approval prior to the meeting of their respective budget
committees.

The AAAAI and ACAAI have agreed to pay the publication cost of the parameters. This expense will not be included in the budget.

Occasionally, the sponsoring organizations may wish to provide supplemental funds for specific projects.

Task Force members are required to submit documentation of their expenses for travel, etc. These are submitted to the Joint Council office in a timely fashion.
The Joint Council then forwards them to the AAAAI and ACAAI - dependent upon which organization the Task Force member represents.

By mutual agreement, practice parameters developed by the Joint Task Force are published alternately in the Journal of Allergy and Clinical Immunology and the
Annals of Allergy, Asthma and Immunology. Sale or distribution of reprints is handled by the Joint Council.

Practice Parameters can be found on the website of the Joint Task Force on Practice Parameters (http://www.allergyparameters.org) as well as the websites of the
AAAAI, ACAAI, and JCAAI. Most of the practice parameters can be found on the National Guidelines Clearinghouse (NGC), the government repository (AHCRD) for guidelines or parameters, and
may be obtained from the journal, in which they are published.

The promotion of the practice parameters is generally the responsibility of the sponsoring organizations.

Selection of Parameter Topic

The JTFPP was given the assignment of developing practice parameters for conditions managed or procedures performed by allergist/immunologists. These include, but are not limited to the following
conditions: anaphylaxis, asthma, atopic dermatitis, contact dermatitis, food hypersensitivity, immunodeficiency, ocular allergy, rhinitis, sinusitis, stinging insect, urticaria, as well as
procedures such as allergy diagnostic testing and allergen immunotherapy. Practice parameters usually therefore, relate to a clinical condition (e.g. allergic rhinitis), procedure (e.g.
immunotherapy), or area of concern (e.g. adverse reactions to vaccines). The need for a particular parameter may be obvious, but also may emerge from other events, e.g. concern about morbidity or
mortality in a given population, evidence that a treatment or procedure offers improvement in patient outcome, uncertainly about the appropriateness of healthcare processes, or the need to use
resources more efficiently in providing care.

A great deal of emphasis in the future will be placed on updating current practice parameters. The Task Force is committed to attempting to update each practice parameter every five years,
although the rapidity of development may depend on time constraints and events in that area. Developing more focused parameters will be a priority in the future. In each updated parameter, new
developments since the last published parameter will be identified. This may include conclusions regarding effectiveness of treatment, as well as highlight gaps in evidence, and identify which
are the areas that need future research.

Specific questions that need to be answered by the evidence will be identified. Answers to these questions will then be utilized to justify conclusions about effectiveness of treatment, highlight
gaps in evidence, and identify those areas that need future research.

General Principles for Development of a Parameter

Practice parameters should be concise

Parameters should be based on state-of-the art up-to-date references; abstracts, case reports and review articles are generally not included.

Updated parameters do not necessarily have to include all sections from the original document unless a significant revision is required.

Practice parameters should be evidence-based.

Repetition should be avoided as much as possible

Practice parameters should be designed to be of utility to the practicing physician

Practice parameters should allow for variations in practice depending on specific clinical situations and on the judgment of the provider. Management of
patients should be individualized based on evidence.

Practice parameters should not include statements that support unproven tests or inappropriate use of proven tests.

Workgroups

Selection of Workgroup Chair and JTF Liasion:

After a topic for a parameter has been chosen, the JTFPP selects an individual to chair the workgroup that has the responsibility of developing the initial draft of a parameter on this
topic. The workgroup chair next selects the individuals who will serve on that workgroup.

The JTFPP also selects one task force member to serve as liaison to the workgroup chair. The liaison communicates with and advises the workgroup chair with regard to issues related to the
development of the parameter, e.g., the format and outline of the document, as well as time frames for completion of the document. The liaison is responsible for making the JTFPP aware of the
status of parameter development.

Responsibilities of the Workgroup Chair:

The workgroup chair should develop an outline of the planned practice parameter in conjunction with the JTFPP liaison and create assignments for each member of the workgroup. This plan
should be submitted to the JTFPP for comment. After the chair has received comments from the JTFPP, a timeline for the completion of the first and subsequent drafts of the parameter should
be developed.

The workgroup chair is responsible for providing a report to the JTFPP liaison on at least a quarterly basis regarding the status of the parameter. A template for this report will be
provided to the JTFPP liaison who will complete it in conjunction with the workgroup chair. This report should include a roster of the workgroup members, their individual assignments and an
assessment of their progress with an estimate for time to completion. In addition, under the direction of the workgroup chair, the workgroup should interact periodically to review the
entire document. Such interaction should ensure that the document represents a consensus of workgroup members.

The final decision for who will be on the workgroup will be made by the work group chair, recognizing that each member of the workgroup must be willing to devote time to individual review of
relevant evidence, e.g. systematic literature review, summarize this information, and to interact with the group during the process of translating this evidence into a clinical practice
parameter. Each member needs to understand that the end product is a group effort and that the individual information, submitted written summaries, and recommendations may be modified by the
group and/or subsequent reviewers. Workgroup members are not authorized to provide official interpretation of a parameter.

The workgroup chair is responsible for ensuring that the workgroup functions effectively and that it achieves its goals. While the workgroup chair must be familiar with the management of
the condition or procedure for which the parameter is being developed and the data that supports the recommendations made in the parameter, the workgroup chair does not necessarily have to be
considered an expert in that area. The workgroup chair should not be an advocate for a particular point of view on the topic to the exclusion of other points of view. The workgroup
chair should stimulate discussion, help the workgroup identify where there is agreement and disagreement and help the workgroup arrive at a consensus regarding how the evidence should be applied
to the parameter that is being developed.

The workgroup chair represents the workgroup in interactions with the JTFPP. In this regard, the chair should participate in conference calls with the JTFPP as necessary as well as
face-to-face meetings and be prepared to present divergent viewpoints on controversial issues.

The workgroup chair is responsible for monitoring the activities of the individual workgroup members. Members who do not meet their responsibilities may be asked to resign from the
workgroup and may be replaced.

To fulfill the goals for updating parameters, the JTFPP may ask the workgroup chair to develop a plan for updating that parameter even as the parameter is being published.

Responsibilities of the Task Force Liaison:

The JTFPP will select one JTFPP member to serve as liaison to the workgroup chair.

The JTFPP liaison communicates with and advises the workgroup chair in regard to the development of the parameter, e.g. the format and outline of the document, time frames for completion of each
draft of the parameter. Interaction between the JTFPP liaison and the workgroup chair should occur frequently to ensure that the parameter is developing appropriately and in a timely
manner.

The JTFPP liaison is responsible for reporting the status of the parameter to the JTFPP on a regular basis and leading the discussion in conjunction with the workgroup chair when the workgroup’s
draft of the parameter is submitted to the JTFPP for their review.

Workgroup Balance:

The workgroup should consider identifying, whenever possible, all the constituencies whose activities would be covered by a practice parameter and solicit their input into the process when
appropriate. While it may not be practical to involve other specialty groups in the forming of the workgroup, representatives from other related groups can add balance and may produce more
authoritative parameters. Therefore, when the practice parameter involves areas where there is common interest with other specialties, e.g. sinusitis or asthma, the addition of an
otolaryngologist or pulmonary specialist to the workgroup should be considered.

Consideration should also be given to balancing the presence of allergist/immunologists who have a pediatric practice with those who have predominantly an adult practice as well as those who
function in an academic environment and those who are primarily in private practice. It is also important that the workgroup chair consider the number of individuals who would function most
efficiently in the area of the parameter being developed. Too few members may limit adequate discussion while too many members may make it difficult for the group to function. In
order to ensure adequate balance, the JTFPP should review the proposed selection of workgroup members before the final selection. Although balance is desired, the goal of developing the
best possible document must always be the primary goal. Workgroup members will be evaluated in regard to conflict of interest, disclosure and work progress periodically by the JTFPP.

Resources Available to Workgroups:

Online web conferencing system

Access to conference calls. These are arranged through the JCAAI office.

The workgroup chair will be provided with a copy of EndNote to track references. Other copies may be provided to workgroup members if needed.

One or more face-to-face meetings may be held if deemed necessary by the workgroup chair and approved by the JTFPP.

Availability of administrative help

Review Process

Review by the JTF:

Once the workgroup has finished developing the initial draft of the practice parameter, it should be submitted to the JTFPP liaison. The JTFPP liaison will do an in-depth review in consultation
with the workgroup chair before submission to the entire JTFPP. If the parameter is found to be seriously deficient, the document may need to be returned to the workgroup for modification.
Occasionally, extensive modifications may be needed prior to review by the entire JTFPP. The timeframe for this process may vary due to workload and time constraints.

Once an adequate draft has been developed by the workgroup, the JTFPP will review the submitted practice parameter in detail on a series of weekly one-hour telephone conference calls and possibly
one or more face-to-face meetings. Presentation of the practice parameter to the entire JTFPP is made by the JTFPP liaison and workgroup chair, highlighting areas of contention or statements that
lack supporting evidence in the literature.

Review by the Sponsoring Organizations and General Membership:

Once the JTFPP has reviewed the parameter and appropriate changes have been made, the draft document is sent to the AAAAI and the ACAAI for their official review*. The AAAAI and ACAAI select
individuals to review the document. The number of individuals selected is at the discretion of the two sponsoring organizations. In some cases, a particular committee in either the
AAAAI or the ACAAI may be an appropriate review group. The turnaround time for review by the AAAAI and ACAAI has been between 2 to 3 weeks, although such review may take longer.

A draft version of each parameter also is sent to the AAAAI, ACAAI for inclusion on their websites for the purpose of obtaining comments from the membership of these organizations. The members of
the AAAAI and ACAAI are also given 3 weeks to review the parameter. All comments that are received from official reviewers, as well as comments from the general membership prior to the deadline,
are reviewed carefully by the JTFPP. Based on these comments, more extensive review of the literature may be required and a JTFPP member may need to directly contact a reviewer to discuss the
issue with him/her. In addition, the JTFPP will produce a point-by-point response to comments that are provided by the sponsoring organizations.

*Note: The Joint Council of Allergy, Asthma & Immunology does not officially review the practice parameters beyond having one representative on the Taskforce.

Final review by the JTFPP Liaison and Workgroup Chair:

Once appropriate recommendations have been incorporated into the document, the parameter is once again reviewed by the JTFPP liaison and workgroup Chair for any final omissions and to check for
format uniformity. After that, the parameter is designated as ready for publication.

Once a parameter is designated as ready for publication, it is assigned either to the Annals of Allergy, Asthma & Immunology or to the Journal of Allergy and Immunology on an
alternating basis. The JTFPP liaison will contact the editor of the appropriate publication to let him/her know that the document is ready for submission, and to remind them of the special nature
of these documents. In particular, that the document already has been extensively reviewed and that no further review should be necessary to avoid unnecessary delay in publication. In
addition, a cover letter from the JCAAI will be provided.

Format of Practice Parameter

Note: Practice parameters should follow the outline as listed below as much as is feasible.

Disclaimer Statements:

This Practice Parameter is prepared for allergists/immunologists (with the assistance of dermatologists) on behalf of the AAAAI, ACAAI and the JCAAI. As in any specialized area of medical
expertise, some exceptions from the parameters can be expected to occur as future research modifies and/or expands the current body of knowledge about (name of disease or problem to which the
parameter pertains). Further, in recognition of the fact that total adherence to these Parameters is not always possible, a divergent approach in exceptional patients beyond the framework of
these parameters should not necessarily be construed as sub-standard, provided that such methods are necessitated by unusual circumstances and are based on validated, medical principles.

The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) jointly accept responsibility for publishing the various practice
parameters. The parameters are complete and comprehensive documents at the time of publication. The medical environment is a changing environment and not all recommendations will be appropriate
for all patients. Because these documents incorporate the efforts of many participants, no single individual, including those who serve on the JTFPP, is authorized to provide an official AAAAI,
ACAAI or JCAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI can be directed to the
Executive Offices of the AAAAI, the ACAAI, and the JCAAI. These parameters are not designed for use by pharmaceutical companies in drug promotion.

Requests for Reprints should be addressed to:

Joint Council of Allergy, Asthma and Immunology

50 N. Brockway St., #3-3

Palatine, IL 60067

Authors:

The first author is either the Workgroup Chair or JTFPP Liaison depending on time and effort expended. Name, title and academic affiliation will be
listed.

Workgroup members are listed either alphabetically or by amount of work contributed. Name, title and academic affiliation will be listed.

JTFPP members are listed alphabetically or by amount of work contributed. Name, title and academic affiliation will be listed.

Official reviewers are recognized and acknowledged if they have fulfilled their responsibilities as reviewers.

Preface:

The preface is intended to introduce the reader to the practice parameter. To do this, it generally should include the background of the topic including why it is important to the practicing
allergist/immunology, a brief description of previous practice parameters on the same or similar topic, if any, and how the current document adds to that knowledge. Topic-related challenges and
controversies may be described here along with acknowledgement of extra effort made by individuals, particularly those who are not listed as authors.

New Developments:

This section includes new developments that have occurred since the last parameter was published, as well as changes in approaches to management. This concise section may include a tabular
format that will allow comparison with previous recommendations. The number of references for this section should be limited to 25. This section will be short, focused and will be
included in the portion of the parameter published in print.

Glossary (if needed):

The glossary is a list of words, phrases and terms, usually in alphabetical order, that need to be defined for the best understanding of the practice parameter. In many instances, the glossary is
used to describe how commonly used phrases are defined for the purpose of the specific document when they might have various meanings to different readers.

Executive Summary:

The Executive Summary is a concise summary of the salient points from the practice parameter and will be, along with the Preface and New Developments sections, published in print. (The
entire parameter will be published online.) Ideally, the Executive Summary should be consistent with the current policy of the editors of the Journal of Allergy and Clinical Immunology
(JACI) and the Annals of Allergy and Immunology. As the JTFPP understands the current policy of these journals, the executive summary would be 10-15 pages with up to 25 references.
The Executive Summary should ideally follow the same order as the full document and describe its contents briefly with an explanation of important concepts. Although the Executive Summary does
not include all of the information contained in the full practice parameter, it should stand on its own for the reader who might choose to read only this section.

Algorithm (when indicated):

An algorithm is a diagram that displays the sequential steps that are required to perform the statements outlined in the practice parameter. Algorithms usually consist of steps to take
(rectangles), decision points (diamonds), and connectors from one step to the next. Steps and decision points should be numbered consecutively and include a brief statement of the step or
decision to be made. (See annotations)

Annotations:

Annotations are brief descriptions of the procedures to be performed for each step or decision point in the algorithm. Annotations should contain sufficient stand alone information to help
providers as they manage patients. Annotations do not require references since they are present in the text of the full document.

Summary statements:

Summary statements are concise actionable recommendations for evaluating or managing patients. Summary statements should be supported using evidence-based medicine. In particular, each statement
should be accompanied by an indicator of the strength of evidence that supports it. Summary statements should only reflect key points in the parameter that are clinically relevant. They are
followed by text that supports the summary statement and by references that support the text for the summary statement. References should be graded according to how robust the
evidence is.

Evidence-Based Commentary:

The JTFPP is working on implementing a more comprehensive grading system to identify the degree to which the database supporting statements in the parameters are evidence-based.

Implementation tools:

Forms, pictures, tables, figures, surveys, and devices can be considered.

Measurement of Outcomes:

If outcome tools are available to indicate the outcome of the JTFPP recommendations, this data should be included. The effect of the parameters should be validated by outcome variables.

References:

All references should be placed in an Endnote library. This is critical since there is no simple way to otherwise insert, delete or reorder references if this is not done. The number of
references should be limited in the Executive Summary and the New Developments Sections. The original source of information should be utilized rather than review articles. Case
reports and abstracts should generally not be used unless they are compelling and there is no further data on this topic. The workgroup should provide the JTFPP with all of the referenced
articles in their entirely, not just the abstracts, for their review on-line.

Publication Policy

Submission of a new parameter, e.g. Environmental assessment and exposure reduction of rodents: a practice parameter, will be made to the journal that did not publish the last
new parameter. For example, the new parameter on rodent allergy went to the Annals of Allergy, Asthma and Immunology, so the next new parameter will go to the Journal of Allergy and Clinical
Immunology.

Submission of an updated parameter willbe made to the journal that did not publish the last published parameter on this topic,e.g. the 2011
publication of the parameter on Stinging Insect Hypersensitivity was published in the Journal of Allergy and Clinical Immunology, so the next update on this parameterwill be
submitted to the Annals of Allergy, Asthma and Immunology.

Using this approach, it is possible that one journal could receive more than one parameter in a row. In order to keep the sponsoring organizations aware of the status of specific parameters
in development, the TF will be posting, on the TF website (http://www.allergyparameters.org), the progress of these parameters. We will be glad to answer any questions on this issue.